Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251719
Status:
COMPLETED
Last Update Posted:
2012-02-03
First Post:
2005-11-08
Brief Title:
Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR 60 mg Once-daily QD and 90 mg QD and an Active Comparator Lansoprazole 30 mg QD on Healing of Erosive Esophagitis
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study to assess the efficacy and safety of 8 weeks of treatment with Dexlansoprazole modified release MR60 mg daily and 90 mg daily compared to Lansoprazole 30 mg daily in healing subjects with endoscopically proven erosive esophagitis
Detailed Description:
This is a Phase 3 randomized double-blind multi-center active-controlled 3-arm study with an 8 week treatment period This study will compare the efficacy of Dexlansoprazole MR 60 mg and 90 mg with that of Lansoprazole 30 mg when administered orally as a single daily dose in the morning before breakfast The study is designed to evaluate healing of erosive esophagitis and the effect of the therapy on relieving gastroesophageal reflux disease related symptoms The study consists of two periods a screening period maximum 21 days and a treatment period which will last up to 8 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1114-0058 | REGISTRY | WHO | None |